AKINCT04266834
Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization
A study testing Experimental Arm in people with AKI and Contrast-induced Nephropathy, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- AKI, Contrast-induced Nephropathy
- What is being tested?
- Experimental Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Board-certified in cardiology for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Averaging at least one day per month performing invasive or interventional cardiology procedures over the last six months
- English speaking
- Access to the internet
- Informed, signed and voluntarily consented to be in the study
Who cannot join
- Non-English speaking
- Unable to access the internet
- Do not voluntarily consent to be in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization: A CPV® Randomized Controlled Trial
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making.
Read the detailed description
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making. Data from this study will better illuminate the clinical use cases with the most significant impact on clinical decision making (and thus the largest potential clinical utility) and the associated physician characteristics (e.g., age, practice setting, training) associated with test adoption.
This study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions. CPVs are a unique and scalable tool that standardizes practice measurement by having all providers care for the same (virtual) patients. With all providers caring for the same patients, the CPVs generate unbiased data that yields powerful insights into clinical decision making and how these decisions change with the introduction of a new product or solution. Data from the CPVs can quickly demonstrate the clinical utility of a solution, be published in peer-reviewed literature, inform marketing strategies and positively impact coverage and reimbursement decisions.
The study is a prospective cohort trial with six steps:
- Enrollment: The study will enroll 166 practicing cardiologists who perform invasive or interventional procedures in the U.S. and are determined to be eligible by an eligibility screener.
- Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
- Randomization: The 166 cardiologists will be randomized into equally-sized (83) control and intervention arms.
- CPVs (First Round): Physicians will complete three randomly-assigned CPV patient simulations in random order. Cases will be identical across the intervention and control arms. All cases are presented on an online platform, participants are provided with unique weblinks, accessible via any internet-connected computer.
- Education: The intervention-arm cardiologists will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the L-FABP test. These materials may be comprised of a slide deck, fact sheet, webinar, or case studies.
- CPVs: Physicians will then complete three additional CPV patient simulations in random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive L-FABP test results at an appropriate point in each simulated case in the post-intervention round.
- Conditions
- AKI, Contrast-induced Nephropathy
- Being tested
- Experimental Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ArmOther
First, these providers will receive educational materials (e.g. a slide deck and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the Hikari DX L-FABP test.
Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the L-FABP test at the clinically-appropriate point in each case.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: Receives: Other: Experimental Arm |
| Control | No intervention | These providers will complete two rounds of three simulated patient cases (CPVs) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPV-measured pre-/post-difference in quality scores between intervention and control physicians
All physicians' completed simulated CPV cases are scored based upon the quality of care provided. This measure CPV-measured pre-/post-difference in these care quality scores between control physicians using standard of care diagnostic tools and intervention physicians with access to L-FABP test results, including by use case types.
Measured: 2-4 weeks
CPV-measured cost difference
Difference in expected cost of care between control and intervention physicians. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, including by each use case, and multiplying by Medicare reimbursement rates for these interventions/levels of care, and/or by modeling the incidence of complications and calculating associated costs per above.)
Measured: 2-4 weeks
Secondary outcomes (1)
Baseline variation in CPV-measured quality scores
All physicians' completed simulated CPV cases are scored based upon the quality of care provided. This measure assesses the baseline levels of care quality variation in the work-up and management of patients at risk for CIN, including by use case types.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Dec 2019
- Primary completion1 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AKIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll practicing cardiologists in the US. All eligible and consented participants will be randomly assigned to either a control or intervention arm. All participants complete two rounds of three patient simulations. The intervention arm only will receive educational material about the Hikari L-FABP test in between these two rounds, and be provided simulated L-FABP test results in the second round of the simulated cases.
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hikari DX
- Responsible party
- Sponsor
- Investigators
- John Peabody, MD, PhD, Principal investigator, President, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266834
- Sponsor's protocol ID
- 01CMC2019
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17.
PubMed 30328782Peabody JW, Strand V, Shimkhada R, Lee R, Chernoff D. Impact of rheumatoid arthritis disease activity test on clinical practice. PLoS One. 2013 May 7;8(5):e63215. doi: 10.1371/journal.pone.0063215. Print 2013.
PubMed 23667587Solon O, Woo K, Quimbo SA, Shimkhada R, Florentino J, Peabody JW. A novel method for measuring health care system performance: experience from QIDS in the Philippines. Health Policy Plan. 2009 May;24(3):167-74. doi: 10.1093/heapol/czp003. Epub 2009 Feb 18.
PubMed 19224955Peabody J, Martin M, DeMaria L, Florentino J, Paculdo D, Paul M, Vanzo R, Wassman ER, Burgon T. Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices. PLoS One. 2016 Dec 30;11(12):e0169064. doi: 10.1371/journal.pone.0169064. eCollection 2016.
PubMed 28036350Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008.
PubMed 15545677
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04266834
- Acronym / sponsor ID
- 01CMC2019
- Conditions
- AKI, Contrast-induced Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Hikari DX
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making.
Detailed description
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making. Data from this study will better illuminate the clinical use cases with the most significant impact on clinical decision making (and thus the largest potential clinical utility) and the associated physician characteristics (e.g., age, practice setting, training) associated with test adoption.
This study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions. CPVs are a unique and scalable tool that standardizes practice measurement by having all providers care for the same (virtual) patients. With all providers caring for the same patients, the CPVs generate unbiased data that yields powerful insights into clinical decision making and how these decisions change with the introduction of a new product or solution. Data from the CPVs can quickly demonstrate the clinical utility of a solution, be published in peer-reviewed literature, inform marketing strategies and positively impact coverage and reimbursement decisions.
The study is a prospective cohort trial with six steps:
- Enrollment: The study will enroll 166 practicing cardiologists who perform invasive or interventional procedures in the U.S. and are determined to be eligible by an eligibility screener.
- Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
- Randomization: The 166 cardiologists will be randomized into equally-sized (83) control and intervention arms.
- CPVs (First Round): Physicians will complete three randomly-assigned CPV patient simulations in random order. Cases will be identical across the intervention and control arms. All cases are presented on an online platform, participants are provided with unique weblinks, accessible via any internet-connected computer.
- Education: The intervention-arm cardiologists will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the L-FABP test. These materials may be comprised of a slide deck, fact sheet, webinar, or case studies.
- CPVs: Physicians will then complete three additional CPV patient simulations in random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive L-FABP test results at an appropriate point in each simulated case in the post-intervention round.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll practicing cardiologists in the US. All eligible and consented participants will be randomly assigned to either a control or intervention arm. All participants complete two rounds of three patient simulations. The intervention arm only will receive educational material about the Hikari L-FABP test in between these two rounds, and be provided simulated L-FABP test results in the second round of the simulated cases.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Experimental ArmExperimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: |
| Control | No intervention | –These providers will complete two rounds of three simulated patient cases (CPVs) only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Board-certified in cardiology for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Averaging at least one day per month performing invasive or interventional cardiology procedures over the last six months
- English speaking
- Access to the internet
Key exclusion criteria (3 listed)
- Non-English speaking
- Unable to access the internet
- Do not voluntarily consent to be in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental ArmFirst, these providers will receive educational materials (e.g. a slide deck and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the Hikari DX L-FABP test. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the L-FABP test at the clinically-appropriate point in each case. | Other | Experimental |
Primary outcome
CPV-measured pre-/post-difference in quality scores between intervention and control physicians
Time frame: 2-4 weeks
All physicians' completed simulated CPV cases are scored based upon the quality of care provided. This measure CPV-measured pre-/post-difference in these care quality scores between control physicians using standard of care diagnostic tools and intervention physicians with access to L-FABP test results, including by use case types.
CPV-measured cost difference
Time frame: 2-4 weeks
Difference in expected cost of care between control and intervention physicians. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, including by each use case, and multiplying by Medicare reimbursement rates for these interventions/levels of care, and/or by modeling the incidence of complications and calculating associated costs per above.)
1 secondary outcome
Baseline variation in CPV-measured quality scores
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 30328782Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17.
- Background: PubMed 23667587Peabody JW, Strand V, Shimkhada R, Lee R, Chernoff D. Impact of rheumatoid arthritis disease activity test on clinical practice. PLoS One. 2013 May 7;8(5):e63215. doi: 10.1371/journal.pone.0063215. Print 2013.
- Background: PubMed 19224955Solon O, Woo K, Quimbo SA, Shimkhada R, Florentino J, Peabody JW. A novel method for measuring health care system performance: experience from QIDS in the Philippines. Health Policy Plan. 2009 May;24(3):167-74. doi: 10.1093/heapol/czp003. Epub 2009 Feb 18.
- Background: PubMed 28036350Peabody J, Martin M, DeMaria L, Florentino J, Paculdo D, Paul M, Vanzo R, Wassman ER, Burgon T. Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices. PLoS One. 2016 Dec 30;11(12):e0169064. doi: 10.1371/journal.pone.0169064. eCollection 2016.
- Background: PubMed 15545677Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Peabody, MD, PhD principal investigator
President, QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Arm in people with AKI and Contrast-induced Nephropathy, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPV-measured pre-/post-difference in quality scores between intervention and control physicians (time frame: 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266834, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.